Sherlock Biosciences has entered into a research collaboration with Dartmouth-Hitchcock Health (D-HH) to begin clinical trial of its Sherlock CRISPR SARS-CoV-2 kit for the detection of Covid-19-causing coroanvirus.

The diagnostic company has secured the US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for the kit in May 2020.

The kit , whichis claimed to be the first CRISPR-based diagnostic test to receive FDA EUA, will be used to test clinical samples drawn from patients at D-HH member hospitals.

D-HH research vice chair Gregory J Tsongalis said: “RT-PCR tests have been a mainstay in testing for the global COVID-19 pandemic in the U.S. Unfortunately, the sheer volume of tests demanded by the pandemic, coupled with the dwindling supply of reagents and other consumables needed to conduct RT-PCR, has created a dire need for alternative testing methods.

“We are excited to partner with Sherlock to understand how the company’s novel CRISPR-based test may help circumvent some of the challenges with RT-PCR testing. We look forward to sharing preliminary results soon to assist those using or considering this novel technology to manage patients through the pandemic.”

The Sherlock CRISPR SARS-CoV-2 kit works based on SHERLOCK method

Sherlock Biosciences claimed that its CRISPR SARS-CoV-2 test kit has been designed for conducting high complexity tests in laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA).

The test kit works by programming a CRISPR molecule to detect the presence of the genetic signature for SARS-CoV-2, based on SHERLOCK (specific high-sensitivity enzymatic reporter unlocking) method.

The presence of nucleic acid from SARS-CoV-2 activates the CRISPR enzyme, resulting in the release of a detectable signal, and the test results can be obtained approximately in an hour.

Sherlock Biosciences chief technology officer William J Blake said: “Ultimately, the measure of success for any diagnostic is how it performs in the hands of real customers with real patient samples.

“Working with the exceptional team at Dartmouth-Hitchcock will demonstrate the impact that our CRISPR-based test will have on patients and the pandemic, while revealing opportunities for Sherlock to make additional contributions with our SHERLOCK and INSPECTR platforms.”